[go: up one dir, main page]

CA2691695C - Glp-1-fc fusion protein formulation - Google Patents

Glp-1-fc fusion protein formulation Download PDF

Info

Publication number
CA2691695C
CA2691695C CA2691695A CA2691695A CA2691695C CA 2691695 C CA2691695 C CA 2691695C CA 2691695 A CA2691695 A CA 2691695A CA 2691695 A CA2691695 A CA 2691695A CA 2691695 C CA2691695 C CA 2691695C
Authority
CA
Canada
Prior art keywords
formulation
glp
concentration
fusion protein
stable solution
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
CA2691695A
Other languages
English (en)
French (fr)
Other versions
CA2691695A1 (en
Inventor
Kingman Ng
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Eli Lilly and Co
Original Assignee
Eli Lilly and Co
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=39870243&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2691695(C) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Eli Lilly and Co filed Critical Eli Lilly and Co
Publication of CA2691695A1 publication Critical patent/CA2691695A1/en
Application granted granted Critical
Publication of CA2691695C publication Critical patent/CA2691695C/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/26—Glucagons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/04—Anorexiants; Antiobesity agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Diabetes (AREA)
  • Endocrinology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Hematology (AREA)
  • Zoology (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Obesity (AREA)
  • Dermatology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Emergency Medicine (AREA)
  • Child & Adolescent Psychology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
CA2691695A 2007-07-10 2008-07-09 Glp-1-fc fusion protein formulation Active CA2691695C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US94885507P 2007-07-10 2007-07-10
US60/948,855 2007-07-10
PCT/US2008/069473 WO2009009562A2 (en) 2007-07-10 2008-07-09 Glp-1-fc fusion protein formulation

Publications (2)

Publication Number Publication Date
CA2691695A1 CA2691695A1 (en) 2009-01-15
CA2691695C true CA2691695C (en) 2014-03-18

Family

ID=39870243

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2691695A Active CA2691695C (en) 2007-07-10 2008-07-09 Glp-1-fc fusion protein formulation

Country Status (18)

Country Link
US (1) US20100196405A1 (uk)
EP (1) EP2175834B8 (uk)
JP (1) JP2010533197A (uk)
KR (1) KR20100020516A (uk)
CN (1) CN101730523A (uk)
AT (1) ATE499088T1 (uk)
AU (1) AU2008275180A1 (uk)
BR (1) BRPI0813699B1 (uk)
CA (1) CA2691695C (uk)
DE (1) DE602008005155D1 (uk)
EA (1) EA201070121A1 (uk)
HR (1) HRP20110242T1 (uk)
MX (1) MX2010000380A (uk)
NZ (1) NZ582480A (uk)
RS (1) RS52378B (uk)
UA (1) UA97673C2 (uk)
WO (1) WO2009009562A2 (uk)
ZA (1) ZA201000149B (uk)

Families Citing this family (51)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9867777B2 (en) * 2010-01-19 2018-01-16 Hanmi Science Co., Ltd. Liquid formulations for long-acting G-CSF conjugate
JP5800527B2 (ja) * 2010-03-30 2015-10-28 日東電工株式会社 安定化医薬組成物、安定化医薬組成物溶液製剤、フィルム状製剤及びフィルム状製剤の製造方法
CN102533655A (zh) * 2010-12-21 2012-07-04 青岛黄海制药有限责任公司 高效表达人源重组蛋白GLP1/Fc的CHO-S细胞株及其建立方法
DK3878859T5 (da) 2011-06-10 2024-06-10 Hanmi Science Co Ltd Hidtil ukendte oxyntomodulinderivater og farmaceutisk præparat til behandling af fedme omfattende disse
SI2721062T1 (sl) 2011-06-17 2019-03-29 Hanmi Science Co., Ltd. Konjugat, obsegajoč oksintomodulinski in imunoglobinski fragment, in uporaba le-tega
WO2014014206A1 (en) * 2012-07-20 2014-01-23 University-Industry Cooperation Group Of Kyung Hee University Novel peptide tag and uses thereof
KR101968344B1 (ko) 2012-07-25 2019-04-12 한미약품 주식회사 옥신토모듈린 유도체를 포함하는 고지혈증 치료용 조성물
AR092862A1 (es) * 2012-07-25 2015-05-06 Hanmi Pharm Ind Co Ltd Formulacion liquida de insulina de accion prolongada y un peptido insulinotropico y metodo de preparacion
AR091902A1 (es) 2012-07-25 2015-03-11 Hanmi Pharm Ind Co Ltd Formulacion liquida de un conjugado de insulina de accion prolongada
US10441665B2 (en) 2012-07-25 2019-10-15 Hanmi Pharm. Co., Ltd. Liquid formulation of long acting insulinotropic peptide conjugate
AR094821A1 (es) 2012-07-25 2015-09-02 Hanmi Pharm Ind Co Ltd Formulación líquida de un conjugado de péptido insulinotrópico de acción prolongada
UA116217C2 (uk) 2012-10-09 2018-02-26 Санофі Пептидна сполука як подвійний агоніст рецепторів glp1-1 та глюкагону
MY168536A (en) * 2012-11-06 2018-11-12 Hanmi Pharm Ind Co Ltd Liquid formulation of protein conjugate comprising an oxyntomodulin derivative covalently linked to a non-peptidyl polymer to an immunoglobulin fc region
KR101993393B1 (ko) 2012-11-06 2019-10-01 한미약품 주식회사 옥신토모듈린 유도체를 포함하는 당뇨병 또는 비만성 당뇨병 치료용 조성물
MX2015008114A (es) 2012-12-21 2015-11-06 Sanofi Sa Derivados de exendina-4.
CN104173275A (zh) * 2013-05-21 2014-12-03 深圳翰宇药业股份有限公司 度拉鲁肽注射剂及其制备方法
EP3080150B1 (en) 2013-12-13 2018-08-01 Sanofi Exendin-4 peptide analogues as dual glp-1/gip receptor agonists
TW201609797A (zh) 2013-12-13 2016-03-16 賽諾菲公司 雙重ｇｌｐ－１／升糖素受體促效劑
EP3080152A1 (en) 2013-12-13 2016-10-19 Sanofi Non-acylated exendin-4 peptide analogues
WO2015086729A1 (en) 2013-12-13 2015-06-18 Sanofi Dual glp-1/gip receptor agonists
TW201625669A (zh) 2014-04-07 2016-07-16 賽諾菲公司 衍生自艾塞那肽－４（Ｅｘｅｎｄｉｎ－４）之肽類雙重ＧＬＰ－１／升糖素受體促效劑
TW201625670A (zh) 2014-04-07 2016-07-16 賽諾菲公司 衍生自ｅｘｅｎｄｉｎ－４之雙重ｇｌｐ－１／升糖素受體促效劑
TW201625668A (zh) 2014-04-07 2016-07-16 賽諾菲公司 作為胜肽性雙重ｇｌｐ－１／昇糖素受體激動劑之艾塞那肽－４衍生物
US9932381B2 (en) 2014-06-18 2018-04-03 Sanofi Exendin-4 derivatives as selective glucagon receptor agonists
TWI802396B (zh) 2014-09-16 2023-05-11 南韓商韓美藥品股份有限公司 長效glp-1/高血糖素受體雙促效劑治療非酒精性脂肝疾病之用途
CN104293834B (zh) * 2014-10-11 2018-03-23 上海兴迪金生物技术有限公司 GLP‑1或其类似物与抗体Fc片段融合蛋白的制备方法
KR102418477B1 (ko) 2014-12-30 2022-07-08 한미약품 주식회사 글루카곤 유도체
EP3257524B1 (en) * 2015-02-11 2020-08-26 Gmax Biopharm LLC Stabilized solution preparation of pharmaceutical glp-1r antibody fusion protein
AR105616A1 (es) 2015-05-07 2017-10-25 Lilly Co Eli Proteínas de fusión
AR105319A1 (es) 2015-06-05 2017-09-27 Sanofi Sa Profármacos que comprenden un conjugado agonista dual de glp-1 / glucagón conector ácido hialurónico
TW201706291A (zh) 2015-07-10 2017-02-16 賽諾菲公司 作為選擇性肽雙重ｇｌｐ－１／升糖素受體促效劑之新毒蜥外泌肽（ｅｘｅｎｄｉｎ－４）衍生物
CN107661288A (zh) * 2016-07-29 2018-02-06 江苏泰康生物医药有限公司 含有glp‑1 类似物融合蛋白的稳定液体制剂及其制备
CN107698684B (zh) * 2016-08-03 2021-09-28 广东东阳光药业有限公司 包含突变的免疫球蛋白Fc部分的GLP-1融合蛋白
CN108210890A (zh) * 2016-12-09 2018-06-29 江苏泰康生物医药有限公司 重组人胰高血糖素样肽-1类似物融合蛋白的新型稳定制剂
GB201621987D0 (en) * 2016-12-22 2017-02-08 Archer Virgil L See Archer Sheri A Arecor Ltd Novel composition
RS64666B1 (sr) 2017-06-01 2023-11-30 Lilly Co Eli Dulaglutid za tretman hronične bolesti bubrega
CN119390821A (zh) 2017-08-15 2025-02-07 伊兰科美国公司 兽药用IgG Fc变体
IL274563B2 (en) * 2017-11-21 2023-12-01 Lilly Co Eli Methods of using and compositions containing dulaglutide
CN116143939A (zh) * 2017-11-24 2023-05-23 浙江道尔生物科技有限公司 一种治疗代谢疾病的多重活性蛋白
TWI705820B (zh) 2018-06-22 2020-10-01 美商美國禮來大藥廠 Gip/glp1促效劑組合物
EP3937904A1 (en) 2019-03-15 2022-01-19 Eli Lilly and Company Preserved formulations
CA3177693A1 (en) 2019-04-05 2020-10-05 Eli Lilly And Company Therapeutic uses of dulaglutide
GB201917723D0 (en) * 2019-12-04 2020-01-15 Nv Rose Llc Stable liquid formulations of glucagon-like peptide 1 or analogues thereof
KR102349717B1 (ko) * 2020-03-12 2022-01-11 주식회사 에스엘메타젠 신규 대사증후군 및 그와 관련된 질환 치료용 약학 조성물
CN114053217B (zh) * 2020-08-03 2023-04-18 华兰生物工程股份有限公司 一种Exendin-4-Fc融合蛋白注射制剂及其制备方法
CN112494658B (zh) * 2020-12-04 2024-07-12 苏州药明生物技术有限公司 一种稳定的Fc融合蛋白制剂
CN114685644A (zh) 2020-12-29 2022-07-01 苏州康宁杰瑞生物科技有限公司 一种人glp-1多肽变体及其应用
EP4368636A4 (en) 2021-07-06 2025-07-02 Suzhou Alphamab Co Ltd FUSION PROTEIN AND ITS APPLICATION
EP4683937A1 (en) 2023-03-23 2026-01-28 Eli Lilly and Company Methods of producing fc-containing proteins
CN117143242B (zh) * 2023-10-30 2024-03-29 南京佰抗生物科技有限公司 抗Galectin-3蛋白的单克隆抗体组合物及应用
WO2025122835A2 (en) 2023-12-08 2025-06-12 Eli Lilly And Company Methods of producing fc-containing proteins

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PL1831252T3 (pl) * 2004-12-22 2009-11-30 Lilly Co Eli Preparaty białka fuzyjnego analogu GLP-1

Also Published As

Publication number Publication date
WO2009009562A2 (en) 2009-01-15
KR20100020516A (ko) 2010-02-22
ATE499088T1 (de) 2011-03-15
HRP20110242T1 (hr) 2011-05-31
WO2009009562A3 (en) 2009-07-09
EP2175834B1 (en) 2011-02-23
AU2008275180A1 (en) 2009-01-15
RS52378B (sr) 2012-12-31
US20100196405A1 (en) 2010-08-05
CN101730523A (zh) 2010-06-09
BRPI0813699A2 (pt) 2014-12-30
MX2010000380A (es) 2010-03-29
JP2010533197A (ja) 2010-10-21
HK1141237A1 (en) 2010-11-05
CA2691695A1 (en) 2009-01-15
DE602008005155D1 (de) 2011-04-07
EA201070121A1 (ru) 2010-06-30
EP2175834B8 (en) 2012-08-22
ZA201000149B (en) 2011-04-28
EP2175834A2 (en) 2010-04-21
UA97673C2 (uk) 2012-03-12
BRPI0813699B1 (pt) 2021-06-22
NZ582480A (en) 2011-03-31

Similar Documents

Publication Publication Date Title
CA2691695C (en) Glp-1-fc fusion protein formulation
CN104667264B (zh) 包含胰岛素、烟酰胺和氨基酸的制剂
TWI643637B (zh) 長效胰促泌素肽接合物之液體製劑
US8748376B2 (en) Stable formulations of peptides
JP2011506442A (ja) インスリン分泌性ペプチド結合体の製剤
TW201010729A (en) GIP-based mixed agonists for treatment of metabolic disorders and obesity
BRPI0710651A2 (pt) composições farmacêuticas de hglp-1, expedina-4 e seus análogos e uso das mesmas
JP2001525371A (ja) Ｇｌｐ−１製剤
EA014232B1 (ru) Стабильные белковые препараты
EP4319798B1 (en) Liquid formulations of amylin analogues
Mroz et al. Pyridyl-alanine as a hydrophilic, aromatic element in peptide structural optimization
TWI897893B (zh) 含有血清白蛋白與生長激素之融合蛋白質之水性醫藥組成物
CN107205925A (zh) 液体药物组合物
EP4121003A1 (en) Liquid formulations of glucagon analogues
JP2004513069A (ja) ペプチド医薬処方
HK1141237B (en) Glp-1-fc fusion protein formulation
CA3240994C (en) Liquid formulations of amylin analogues
WO2024141054A1 (zh) 包含融合蛋白的药物组合物及其用途
HK40104625A (en) Liquid formulations of amylin analogues
HK40104625B (en) Liquid formulations of amylin analogues
WO2021263040A1 (en) Stable peptibody formulations

Legal Events

Date Code Title Description
EEER Examination request